|2003P-0029 - Use of Ozone-Depleting Substances; Removal of Essential-Use Designations (Albuterol)|
|FDA Comment Number :||EC25|
|Submitter :||Dr. James Ransom||Date & Time:||07/19/2004 05:07:10|
|Organization :||Topeka Allergy and Asthma Clinic|
| It is clear to me that the financial impact of forcing patients to buy non-generic albuterol dispensers will result in unwarranted costs and decreased compliance, with little "ozone layer" benefit. Regardless of where one stands on the question of the effects of medical devices on the ozone layer, practitioners know that most albuterol devices are prescribed as rescue inhalers and often are seldom (and sometimes never) used before they are outdated. Therefore, cost is a vital concern to the consumer, and to the physician who wants the patient to have this device. At the same time, the existence of these small capacity (and often unused) devices does little to threaten the ozone layer. Therefore, until a generic version of non-CFC albuterol is available for sale at approximately the same price as the current generic unit, I strongly urge the FDA to postpone action on this matter. To do otherwise is not in the public interest.
James H. Ransom, MD